Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
www.fda.gov →Official Site

Have an unsafe medication, device, or food to report?

Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.

How to report to FDA →
68,659 recalls
High RiskFDA
J&s Group
Frozen Oysters (IQF), Net Weight: 30 lbs (6/5lbs).
Seafood·779 affected·Jun 18, 2012
High RiskFDA
Ultradent Products, Inc.
Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, wh...
Food·17 affected·Jun 18, 2012
High RiskFDA
Ultradent Products, Inc.
Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, ...
Food·668 affected·Jun 18, 2012
High RiskFDA
Ultradent Products, Inc.
Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with bla...
Food·4,083 affected·Jun 18, 2012
High RiskFDA
Red Chamber Company
Frozen Korean Oyster Meat I.Q.F.: , 1) 40x8oz., UPC 19964 30091; 2) 1x25lbs, .; 3) 5x4lbs.UPC 19964 30092
Meat & Poultry·1 affected·Jun 18, 2012
RecallFDA
Stat Rx Usa
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16...
Ophthalmic Drugs·22 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung syst...
Cardiac Devices·484 affected·Jun 18, 2012
High RiskFDA
Cardiovascular Systems, Inc.
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxid...
Medical Devices·27 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 ho...
Medical Devices·461 affected·Jun 18, 2012
High RiskFDA
Varian Medical Systems, Inc. Oncology Systems
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Va...
Medical Devices·7,113 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours ...
Medical Devices·26 affected·Jun 18, 2012
High RiskFDA
Safe N Simple, Llc
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Medical Devices·17,592 affected·Jun 18, 2012
High RiskFDA
Hill-rom, Inc.
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
Surgical Devices·7,843 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorpo...
Medical Devices·648 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours...
Medical Devices·1,096 affected·Jun 18, 2012
High RiskFDA
Synthes Usa Hq, Inc.
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. ...
Medical Devices·1,602 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 ho...
Medical Devices·310 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung ...
Cardiac Devices·286 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours ...
Medical Devices·274 affected·Jun 18, 2012
High RiskFDA
Deroyal Industries Inc
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
Surgical Devices·303 affected·Jun 16, 2012
CriticalFDA
Hannaford Bros.
Hannaford brand Mini Frosted Cookies, 10 oz UPC # 4126872374
Bakery & Grains·990 affected·Jun 15, 2012
High RiskFDA
Coca-cola Refreshments Usa, Inc.
Coca Cola Cherry Zero, 20 fl. oz. (1.25 pt), The Coca Cola Company.
Food·119 affected·Jun 15, 2012
High RiskFDA
Cj Foods, Inc., A Division Of Cj America
CJ Het Oyster (CJ Frozen Oyster), 40x8oz.. Material#912329, Frozen Oyster (KR 12 SP 050110), Material#912330, Frozen Oyster (KR 12 SP...
Seafood·1,635 affected·Jun 15, 2012
High RiskFDA
Wang Globalnet
Surasang Chanbada Frozen Oyster I.Q.F (8oz), 40pack/case
Seafood·1,572 affected·Jun 15, 2012
High RiskFDA
Itoen (usa) Inc
Itoen Green Tea 11.5 fl oz (340 mL) can. Natural Source of Antioxidants; 0 calories, no sugar: ITO-EN USA Inc. 125 Puuhale Road H...
Beverages·10 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Encision, Inc.
AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosu...
Surgical Devices·48 affected·Jun 15, 2012
CriticalFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilitie...
Medical Devices·43,862 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Korean Farm, Inc.
IQF Oysters 3lbs, Assi Brand, Item# 20083K,10x3 lb; Oyster Block, Assi Brand, item# 20085K, 30x1 lb; Oysters 8 oz - Tiny, Assi Bran...
Seafood·638 affected·Jun 14, 2012
High RiskFDA
Christian Cheese, Llc
Christian Cheese Horseradish Cheddar Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetabl...
Dairy·0 affected·Jun 14, 2012
High RiskFDA
Christian Cheese, Llc
Christian Cheese Sun-Dried tomato Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable ...
Dairy·15 affected·Jun 14, 2012
High RiskFDA
Christian Cheese, Llc
Christian Cheese Vegetable Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, On...
Dairy·15 affected·Jun 14, 2012
High RiskFDA
Christian Cheese, Llc
Christian Cheese Blackberry Wine Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Re...
Dairy·0 affected·Jun 14, 2012
High RiskFDA
Namias Dba Chonita Foods
Sonoran Rice, 14 lbs (224 oz). Chonita Foods 847 E. 18th St. Tucson, AZ 85719.
Food·22 affected·Jun 14, 2012
High RiskFDA
Christian Cheese, Llc
Christian Cheese Ranch Bacon Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, ...
Dairy·15 affected·Jun 14, 2012
High RiskFDA
Kimberly-clark Corporation
Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Dis...
Drugs·5,268 affected·Jun 14, 2012
High RiskFDA
Dukal Corp.
ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (ite...
Drugs·0 affected·Jun 14, 2012
High RiskFDA
Kimberly-clark Corporation
Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by...
Drugs·8,994 affected·Jun 14, 2012
High RiskFDA
Dukal Corp.
Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged ...
Drugs·0 affected·Jun 14, 2012
High RiskFDA
Philips Healthcare Inc.
Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic inte...
Medical Devices·226 affected·Jun 14, 2012
High RiskFDA
Integra Life Sci.
The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a S...
Medical Devices·2,389 affected·Jun 14, 2012
High RiskFDA
Orthopediatrics Corp
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients ...
Medical Devices·15 affected·Jun 14, 2012
High RiskFDA
True World Foods San Francisco Llc.
Oyster Frozen Half Shell; 144 Pc/CS Processed by: Dai One Food Co., LTD #150 Jun-RI, Sanyang-UP Tongyeong-City Kyungsangnam-DO. ...
Seafood·0 affected·Jun 13, 2012